FLIPPER QoL data support palbociclib–fulvestrant use in postmenopausal breast cancer patients
medwireNews: The quality of life (QoL) of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer remains largely unchanged by the addition of palbociclib to first-line fulvestrant, suggest data from the FLIPPER trial.
Together with the significant improvement in progression-free survival offered by the combination, as previously reported by medwireNews, these QoL data “provide additional support for the benefit of palbociclib to fulvestrant in this patient population,” said presenting author Ariadna Tibau (Hospital de la Santa Creu i Sant Pau, Barcelona, Spain) at the ESMO Breast Cancer Virtual Congress 2021.
In this phase 2 trial, patients were randomly assigned to receive either palbociclib 125 mg for 3 weeks of each 28-day cycle or placebo, both given alongside fulvestrant 500 mg on days 1 and 15 of the first cycle and then once every 28 days. Patient-reported outcomes, assessed using the EORTC QLQ-C30 and QLQ-BR23 questionnaires, were collected from 178 trial participants at baseline, end of treatment, and every 3 months in between.
For the most part, changes from baseline in functional and symptom scales were comparable between the palbociclib and placebo groups, with the exception of global health status, appetite loss, constipation, and systemic therapy side effects, which significantly favored the placebo arm, and sexual enjoyment, which significantly favored the palbociclib arm.
Tibau pointed out, however, that “[t]he overall [health-related] QoL differences favoring [fulvestrant and placebo] were clinically meaningful only for appetite loss,” and added that “on-treatment global health status and quality of life was maintained from baseline in both arms.”
Time to deterioration (TTD) of global health status, defined as the time to a change from baseline of at least 10 points, was shorter among patients who received palbociclib rather than placebo alongside fulvestrant, at a median of 11.1 versus 30.3 months, and a significant hazard ratio of 1.57 in favor of placebo.
Subgroup analyses showed that this between-group difference in TTD was significant only in patients who did not have disease progression, with median durations of 11.1 and 30.3 months among palbociclib- and placebo-treated patients, respectively. There was no such difference among patients with disease progression, among whom the corresponding times were 11.1 and 17.5 months.
Furthermore, “no significant differences were observed between palbociclib treatment and endocrine monotherapy with respect to any other functional and symptom scales,” highlighted the presenter.
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